NCT02182050已完成2 期
A Double-blind, Randomised Phase II Study to Determine Efficacy and Safety of Oral Treatment With BIBF 1120 ES 250 mg Twice Daily Versus 150 mg Twice Daily in Patients Suffering From Advanced Non-small-cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 主要终点
- Tumour response according to response evaluation criteria in solid tumours (RECIST)
研究概览
简要总结
The overall purpose of this phase II trial was to evaluate the efficacy of 250 mg BIBF 1120 twice daily (BID) versus 150 mg BIBF 1120 BID in patients with advanced non-small-cell lung cancer (NSCLC) who had failed at least one prior chemotherapy regimen. In addition, safety data for the two different dosages were collected and analysed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BIBF 1120 ES low dose
Experimental
干预措施: BIBF 1120 ES low dose (Drug)
BIBF 1120 ES high dose
Experimental
干预措施: BIBF 1120 ES high dose (Drug)
Placebo
Placebo Comparator
干预措施: Placebo to BIBF 1120 ES (Drug)
结局指标
主要结局
Tumour response according to response evaluation criteria in solid tumours (RECIST)
时间窗: baseline, every 6 weeks for an expected mean observation duration of 9 months
Time to tumour progression
时间窗: baseline, every 6 weeks for an expected mean observation duration of 9 months
次要结局
- EORTC QLC lung cancer module (QLQ-LC13) score(mean observation duration of 9 months)
- Overall survival(mean observation duration of 9 months)
- Incidence and intensity of adverse events, graded by Common Terminology Criteria (CTCAE) 3.0(mean observation duration of 9 months)
- Changes in vital signs (body temperature, blood pressure, pulse rate, respiratory rate)(mean observation duration of 9 months)
- Maximum plasma concentration (Cmax)(pre-dose, 1, 2, and 3 hours after administration)
- Eastern Cooperative Oncology Group (ECOG) performance score(mean observation duration of 9 months)
- Area under the curve (AUC)(pre-dose, 1, 2, and 3 hours after administration)
- European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire (QLQ) (EORTC QLQ-C30) score(mean observation duration of 9 months)
- Changes in safety laboratory parameters(mean observation duration of 9 months)
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